Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

BMJ op-ed calls molnupiravir authorization ‘premature’ 

By Brian Buntz | March 3, 2022

Molnupiravir

Image courtesy of Merck & Co.

A recent editorial in the British Medical Journal (BMJ) criticized the decisions of British and U.S. health regulators to authorize the use of the antiviral molnupiravir, the COVID-19 antiviral.

The developers of the drug, Merck & Co. (NYSE:MRK) and Ridgeback Biotherapeutics, had announced that molnupiravir lowered the risk of hospital admissions or death by roughly 50% in the 29 days following infection with COVID-19.

WHO recently updated its treatment guidelines to include the drug for high-risk individuals. The organization based its decision on new data from six randomized controlled studies involving 4,796 patients.

Authorizations of molnupiravir will “inhibit further necessary evaluations” and could divert funding from more effective treatments, argued author James M Brophy, a professor of medicine and epidemiology at McGill University Health Center.

Brophy noted that the FDA itself concluded that “it is reasonable to believe that molnupiravir may be effective,” arguing that the phrasing “raises questions about the strength and certainty of the evidence.”

Brophy concluded that the “published results have borderline significance, indicating that even a small number of misclassified outcomes could overturn the significance of the findings.”

Merck & Co. did not immediately respond to a request for comment.

Merck and Ridgeback Biotherapeutics had launched the MOVe-IN study for hospitalized COVID-19 patients and a Phase 3 MOVe-OUT study involving outpatients with COVID-19. Data from the latter was used for authorization.

Brophy also argued that the molnupiravir’s mutagenic mode of action could contribute to the emergence of new SARS-CoV-2 variants.

The WHO recommended active monitoring of the drug for safety.

NEJM profiled molnupiravir late last year.


Filed Under: Infectious Disease
Tagged With: COVID-19 antiviral, Merck & Co., Molnupiravir, Ridgeback Biotherapeutics
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

Related Articles Read More >

covid-19 vaccine
FDA COVID booster pullback jolts vaccine stocks before gains cool
Coronavirus Covid-19 background - 3d rendering
Pregnancy associated with less long COVID: Researchers call for studies on protective biology
How technology advances are helping scientists unlock the mysteries of zoonotic diseases
Novel coronovirus
Advances in next generation vaccine development for SARS-CoV-2
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE